| Treating Attention Deficit Hyperactivity Disorder (ADHD) with traditional Chinese medicine (TCM) has its own unique superiority and distinctive characteristic. For assessing its efficacy objectively, finding out the existing problems in the clinical researches and corresponding solutions, exploring the regularity of diagnosis and treatment, investigating the acting mechanism of compound Chinese medicine. Based on the principle of EBM, the author did some relative studies by using its methods, the thesis includes five parts as follows:The first part: Disscusing the necessity and feasibility to assess the efficacy of Chinese medicine for treating ADHD with the introduction of Evidence-Based Medicine (EBM) concept. It is necessary to evaluate the efficacy of TCM with scientific method, and the methodological characterstic of systematic review proposed by EBM conforms with the development of TCM. Meanwhile, a large number of clinical trials can be used for systematic review, and some systematic reviews and Meta-analyses have been made.The second part: Making systematic review(SR) for the clinical research documents on treating ADHD published from 1990 to 2005. The research design protocal, sample size, diagnostic and curative effect criteria, effective rate, statistical method, follow-up and side-effect are summarizedwith descriptive statistics. A total of 93 documents are involved, including 45 non-clinical controlled trials and 48 controlled trials, 7358 cases were observed. Results: The quantities, of clinical trials increased gradually, especially the number of randomized controlled trials(RCTs). But the research qualities are poor for the methodological shortcomings. The main existed problems are: sample size of trials are not strictly determined; the principle of randomization, control and blindness are not well emploied in RCTs; the application of statistic methods are not proper in many trials; the observations for follow-up and side-effect are not sufficient; there has not been identical, objective and strict measures to evaluate the efficacy. Three meta-analyses are done for the effective rate of compound Chinese medicine compared with Ritalin(the current standard treatment), the effective rate of integration of compound Chinese medicine and Ritalin compared with Ritalin, the recurrent rate of compound Chinese medicine compared with Ritallin respectively. RevMan4.2 software was uesd for the meta-analyses .Results:The total effective rate of compound Chinese medicine has no statistcal difference compared with Ritalin, but shows a better tendency;the effective rate of combined therapy is superior to the mere use of Ritalin, the difference between them is significant, suggesting their superiority clinically;meanwhile, compound Chinese medicine is better than Ritalin in preventing recurrence. Overall, the existing evidences support the value of TCM for treating ADHD.The third part:studying the syndrome treatment regularity of ADHD by collating concerned documents systematically. Among the 93 clinical trials,the method of treatment in 25 trials was based on syndrome differentiation ,fixed prescriptions were used in 49 trials, modified prescriptions were used in another 19 trials. Combining TCM theory with statistic analyses, datas about differentiation, treatment principles, prescriptions and herbs are summarized. The type of syndrome, therapeutic principle, total number of prescriptions and herbs, frequency of herb utilization, herb category are analyzed with frequency distribution method. The results indicate that the main pathogenesis of ADHD is deficiency of Zang-fu function which leads to abnormal mental ,yang is excess and yin is deficient, kidne,liver,heart and spleen are the four concerned organs, its essence lies in the deficiency in the root, deficiency could cause excess syndroms, including yang hyperactivity, excessive fire, phlegm heat and blood stasis. The primary syndrome type is kidney-deficiency and liver-hyperactivity in clinical practice, other commonly syndrome types are deficiency of heart and spleen,excess of liver and heart-fire,deficiency of heart and kidney,deficiency of spleen and excess of liver successively .The basic rule of herb compatibilities is tonify deficiency, mind-tranqulizing and calm the liver. Clear away heat, eliminate phlegm and promote blood circulation are the important compatibilities to strengthen therapeutic effect. Tonic drugs, tranqulize drugs and calm-liver drugs are the key medicines in prescriptions. A total of 90 prescriptions, 119 herbs and mainly 14 classes of drugs are used in this study, the ten most used herbs include yuanzhi(Radix Polygalae),shichangpu(Rhizoma Acori Graminei),shudi(Radix Rhmanniae),gancao((Radi Glycyrrhizae),longgu(Os Draconis),shanzhuyu(Fructus Crataegi),baishao(Radix Paeoniae Alba),guiban(Plastrum Testudinis) and muli(Concha Ostreae),fuling(Poria),yizhiren(Fructus Alpiniae Oxyphyllae) in proper order. From the aboved studies, the core herbs to treat ADHD are induced.The fourth part:Exploring the acting mechanism of compound Chinese medicine for treating ADHD. Observe the influence of Yizhining on the active attention and dopamine of frontal-striatum ring road of SHR(spontaneously hypertensive rats, standard animal model of ADHD).Digital monitor and the method of five-choice Serial reaction time task are used to observe the active attention . Dopamine levels of prefrontal cortex and striatum are detected by HPLT-electrochemical method .The results indicate that Yizhining could improve the active attention of SHR in some degree, and obviously increase the striatum dopamine level, but has no significent effect on that of prefrontal cortex. The experiment showed a trend of dose-effect relationship though there was no statistical difference between low-dose group and high-dose group, It suggests that one of the mechanism of Yizhining relate to its influence on the monoamine neurotransmitter, it regulates the dopamine levels of frontal-striatum ring road lies in increasing the striatum dopamine level, striatum may be one of its functional targets.The fifth part: Suggestions about future research. Clinical trials should be carried out by the request of EBM, design standard research protocol, adopt both western medicine criteria(DSm-IV is recommended)) and TCM standard, pay attention to long-period therapeutic effect and the quality of life. Investigating the main syndromes and types by reviewing relative documents and cases, and formulating the primary syndrome classification criterion with the methods of multivariate analysis and measuring scales by prospective study, then testing its validity and reliability by mult-center gross sample clinical trials, finally the syndrome standardization and therapeutic effect evaluation system could be brought out. Machanism research should adopt generally recognized animal models, integrate with disease pathology,adhere to the identity of TCM theories,treatment methods,prescription and medicine, exploring the acting mechanism of effective prescriptions from different angles, multiple sectors and levels.
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